Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT03011593
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2016-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of UGIR in Adults With Compromised Gut Function and Malabsorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2017-01-03', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gastrointestinal Quality of Life Index (GIQLI) Score', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score', 'timeFrame': '6 weeks'}, {'measure': 'Change in Celiac Disease Questionnaire (CDQ) Score', 'timeFrame': '6 weeks'}, {'measure': 'Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome', 'Crohn Disease', 'Ulcerative Colitis', 'Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '33799455', 'type': 'BACKGROUND', 'citation': "Ryan JJ, Monteagudo-Mera A, Contractor N, Gibson GR. Impact of 2'-Fucosyllactose on Gut Microbiota Composition in Adults with Chronic Gastrointestinal Conditions: Batch Culture Fermentation Model and Pilot Clinical Trial Findings. Nutrients. 2021 Mar 14;13(3):938. doi: 10.3390/nu13030938."}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33799455/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.', 'detailedDescription': 'This prospective, non-randomized, open-label study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption. Adults with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were enrolled in the study and asked to take the study product for 6 weeks. The primary measure of the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency Questionnaire (DSFQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index 19 - 40 kg/m2\n* Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease\n\nExclusion Criteria:\n\n* Gastroenterologic surgery within 3 months before the study period\n* Have a colostomy or ileostomy bag\n* Malignancy within the last 5 years\n* Women who are lactating, pregnant or planning pregnancy during the study period\n* Taking antibiotic, antiparasitic, or antifungal medications\n* Initiation of or changes to supplements or medications within 28 days prior to screening"}, 'identificationModule': {'nctId': 'NCT03011593', 'briefTitle': 'Effect of UGIR in Adults With Compromised Gut Function and Malabsorption', 'organization': {'class': 'INDUSTRY', 'fullName': 'Metagenics, Inc.'}, 'officialTitle': 'Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption', 'orgStudyIdInfo': {'id': 'UGIR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition Support Product', 'description': 'Participants were asked to take a nutrition support product twice per day for a period of 6 weeks.', 'interventionNames': ['Other: Nutrition Support Product']}], 'interventions': [{'name': 'Nutrition Support Product', 'type': 'OTHER', 'otherNames': ['UGIR'], 'description': 'Nutrition support product contains macronutrients, micronutrients, glutamine, and prebiotics. Product is in powder form (41 grams per serving) and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.', 'armGroupLabels': ['Nutrition Support Product']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nikhat Contractor, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Metagenics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metagenics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National University of Natural Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}